Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

Revent Medical International B.V.0 个研究点目标入组 40 人开始时间: 2011年5月1日最近更新: 2016年11月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 40
主要终点: Apnea-Hypopnea Index (AHI)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of OSA with AHI 15-40
•Body Mass Index (BMI) ≤ 32
•Refused or failed Continuous Positive Airway Pressure (CPAP)
•Evidence of airway collapse at soft palate and/or base of tongue

排除标准

•Prior OSA surgery
•Anatomy unable to accommodate implants
•Chronic immunosuppressive therapy or known problems with wound healing
•Type I or II diabetes
•Active systemic infection
•Pregnancy
•Other major medical conditions that could confound outcome measures or interfere with study completion

结局指标

主要结局

Apnea-Hypopnea Index (AHI)

时间窗: 24 months post-procedure

Decrease in polysomnographically measured AHI post-intervention compared to baseline

次要结局

未报告次要终点

研究者

发起方

Revent Medical International B.V.

申办方类型

Industry

责任方

Sponsor

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